Viral Load in Blood and Lymph Tissues in People Living With HIV

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Nov 3, 1999

Keywords

ClinConnect Summary

This clinical trial is studying how the HIV virus behaves in different parts of the body, particularly in lymph nodes compared to the blood. Researchers want to understand if HIV replicates more actively in lymph nodes early in the infection, even when there may not be much virus in the blood. This information could help doctors decide when to start treatment for HIV, as early treatment might be beneficial. The study will include people at various stages of HIV infection, from early to advanced disease, to see how the virus acts in different cases.

To participate in the trial, you need to be at least 18 years old and have a confirmed HIV infection. You should also have a palpable lymph node that can be easily accessed for testing. Participants will undergo blood tests and a biopsy of the lymph node, and they will be asked for permission to use their samples in future studies. It’s important to note that pregnant or breastfeeding women, those with certain medical conditions, and individuals currently abusing substances are not eligible to join. If you qualify, you will be contributing to valuable research that could improve understanding and treatment of HIV.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • 1. HIV status must be documented by a licensed ELISA and confirmed either by Western blot, or plasma viremia.
• • 2. Aged 18 years or older.
• • 3. Ability to give informed, written consent.
• 4. The following laboratory values:
• • 1. Absolute neutrophil count of greater than 1000/mm3.
• • 2. PT, PTT within normal limits (unless PTT is elevated in presence of positive lupus anticoagulant in a participant with no prior history of abnormal bleeding).
• • 3. Adequate blood counts (PLWH: hemoglobin greater than or equal to 9.0 g/dL, HCT greater than or equal to 28%, platelets greater than or equal to 75,000; participants without HIV: hemoglobin greater than or equal to 11.2 g/dL, HCT greater than or equal to 34.1%, platelets greater than or equal to 150,000).
• • 4. Blood pressure less than or equal to 180/100; pulse rate 50-100, unless a lower pulse rate is considered normal for the participant.
• • 5. Participants who do not have HIV will qualify as control participants.
• • 6. Participants must have a clinically palpable lymph node in an easily accessible location.
• • 7. Willingness to allow blood samples to be used for future studies of HIV infection/pathogenesis, undergo genetic testing including HLA testing, and undergo hepatitis screening
• EXCLUSION CRITERIA:
• • 1. Women who are pregnant and/or breast-feeding.
• • 2. Currently abusing alcohol or other drugs, including narcotics or cocaine.
• • 3. Participants with AIDS dementia or with an AIDS related malignancy other than minimal Kaposi's sarcoma.
• • 4. No Aspirin or Non-Steroidal Anti-inflammatory medications (NSIADs) 7 days prior to procedure. Acetaminophen (Tylenol) is permitted at any time.
• • 5. Any medical condition for which the PI feels LN BX might be contraindicated.
• • 6. Participants in which sedation is planned. Use of narcotics (other than as prescribed by a physician) or cocaine less than 1 week prior to the date of biopsy will be excluded.

Trial Officials